Nab-Paclitaxel + Paclitaxel + Ramucirumab for Stomach Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that treatment with therapeutic oral or IV antibiotics within 14 days prior to the start of the trial is not allowed, unless they are prophylactic (preventive) antibiotics and signs of active infection have resolved.
What data supports the effectiveness of the drug Nab-Paclitaxel + Paclitaxel + Ramucirumab for stomach cancer?
Research shows that nab-paclitaxel, a form of paclitaxel, is effective and safe for treating advanced gastric cancer when combined with ramucirumab. Additionally, nab-paclitaxel has been used successfully in other cancers like breast and lung cancer, suggesting its potential effectiveness in stomach cancer.12345
Is the combination of Nab-Paclitaxel, Paclitaxel, and Ramucirumab safe for humans?
Nab-Paclitaxel (also known as Abraxane) has been studied for safety in various cancers, including gastric cancer, lung cancer, and melanoma. It is designed to improve tolerability compared to traditional formulations, and studies suggest it is generally safe for human use, though specific side effects can vary depending on the condition being treated.12346
How is the drug combination of Nab-Paclitaxel, Paclitaxel, and Ramucirumab unique for treating stomach cancer?
This drug combination is unique because Nab-Paclitaxel is a solvent-free form of Paclitaxel that improves solubility and reduces side effects, making it more convenient and potentially safer than traditional Paclitaxel. It is combined with Ramucirumab, which is already a standard treatment, to enhance effectiveness in treating advanced gastric cancer.15789
What is the purpose of this trial?
This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.
Research Team
Yanghee Woo
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for stomach cancer patients with peritoneal metastases, who are ready to try a combination of treatments. Participants should be suitable for second-line chemotherapy and have not had prior PIPAC or allergic reactions to the drugs used in this study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nab-paclitaxel PIPAC intraperitoneally and standard of care paclitaxel and ramucirumab intravenously. Cycles repeat every 8 weeks for up to 3 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes regular assessments every 3 months for the first year, then every 6 months.
Treatment Details
Interventions
- Nab-paclitaxel
- Paclitaxel
- Ramucirumab
Nab-paclitaxel is already approved in United States, European Union, Canada for the following indications:
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
- Metastatic breast cancer
- Non-small cell lung cancer
- Adenocarcinoma of the pancreas
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator